Safety and efficacy of intravenous ferric derisomaltose compared to iron sucrose for iron deficiency anemia in patients with chronic kidney disease with and without heart failure

Ambrosy, A. P., von Haehling, S., Kalra, P. R., Court, E., Bhandari, S., McDonagh, T. and Cleland, J. G.F. (2021) Safety and efficacy of intravenous ferric derisomaltose compared to iron sucrose for iron deficiency anemia in patients with chronic kidney disease with and without heart failure. American Journal of Cardiology, 152, pp. 138-145. (doi: 10.1016/j.amjcard.2021.04.042) (PMID:34162484)

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Abstract

Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Cleland, Professor John
Authors: Ambrosy, A. P., von Haehling, S., Kalra, P. R., Court, E., Bhandari, S., McDonagh, T., and Cleland, J. G.F.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:American Journal of Cardiology
Publisher:Elsevier
ISSN:0002-9149
ISSN (Online):1879-1913
Published Online:20 June 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in American Journal of Cardiology 152: 138-145
Publisher Policy:Reproduced under a Creative Commons licence

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
303944BHF Centre of ExcellenceRhian TouyzBritish Heart Foundation (BHF)RE/18/6/34217CAMS - Cardiovascular Science